510(k) ClearedCE-IVD
Identification of fungal pathogens and resistance markers from positive blood cultures
Technical Specifications
PlatformePlex
MultiplexYes
Target Count15
Sensitivity≥93%
Specificity≥97%
Turnaround Time1.5 hr
Storage Temperature2–8°C
Shelf Life18 months
Pathogen Targets (2)
Sample Types
Blood (whole)
Detection Methods
Multiplex PCR